Prospective Study of Pregnancy in Women With Cystic Fibrosis

A Prospective Study Evaluating Maternal and Fetal Outcomes in the Era of Modulators

Sponsors

Commanditaire principal: Amalia Magaret

Collaborateur: University of Texas
National Jewish Health
Cystic Fibrosis Foundation

La source Seattle Children's Hospital
Bref résumé

In this study, the investigators aim to evaluate changes in lung function in women with cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators.

Description détaillée

Advances in medical treatment, including the use of highly effective CFTR modulators have greatly increased life expectancy in women with CF, but the effects of pregnancy on women with CF are yet unknown. It is anticipated that over 90% of the CF population will be on CFTR modulators in the next few years. More knowledge about the effects of CFTR modulators in pregnancy is needed. This is a prospective, multi-center, observational study to follow pregnant women with CF, conducted at 40 US sites. Women are enrolled in the first trimester of pregnancy and assessed every 3 months during pregnancy and during the first year after delivery, then every 6 months for an additional year. Changes in lung function over the course of pregnancy will be evaluated based on cumulative CFTR modulator use while pregnant while accounting for other factors that may influence changes in pulmonary function: baseline lung function, genotype, history of exacerbations, and pre-existing co-morbid conditions.

Situation globale Not yet recruiting
Date de début 2021-07-16
Date d'achèvement 2025-12-30
Date d'achèvement principale 2025-12-30
Type d'étude Observational
Résultat primaire
Mesure Plage de temps
Forced expiratory volume at one second (FEV1) percent predicted after delivery and restart of modulators 42 weeks
Forced expiratory volume at one second (FEV1) percent predicted after delivery 42 weeks
Inscription 285
État
Admissibilité

Méthode d'échantillonnage: Non-Probability Sample

Critères:

Inclusion Criteria: - Pregnant, intending to continue pregnancy, enrolled in the CFF registry Exclusion Criteria: - None

Le sexe: Female

Âge minimum: 16 Years

Âge maximum: N/A

Volontaires en santé: No

Officiel général
Contact général

Nom de famille: Natallia Cameron, MS

Téléphone: 206-884-7550

Email: [email protected]

Emplacement
Établissement: Contact:
University of Alabama at Birmingham | Birmingham, Alabama, 35294, United States Heather Hathorne [email protected]
University of Arkansas for Medical Sciences | Little Rock, Arkansas, 72205, United States Kathleen Hicks [email protected]
University of California San Diego | La Jolla, California, 92093, United States Jenna Mielke [email protected]
Center for Cystic Fibrosis at Keck Medical Center of USC | Los Angeles, California, 90033, United States Lynn Fukushima [email protected]
National Jewish Health | Denver, Colorado, 80206, United States Alix Wilson [email protected]
University of Florida | Gainesville, Florida, 32610, United States Noni A Graham [email protected]
Joe DiMaggio Children's Hospital | Hollywood, Florida, 33021, United States Doris Alaby [email protected]
Central Florida Pulmonary Group | Orlando, Florida, 32803, United States Kenneth Kesser [email protected]
Emory University | Atlanta, Georgia, 30327, United States Eric A Hunter [email protected]
Saint Luke's Cystic Fibrosis Center of Idaho | Boise, Idaho, 83702, United States Lejla Godusevic [email protected]
Indiana University Medical Center | Indianapolis, Indiana, 46202, United States Lisa Bendy [email protected]
University of Kansas Medical Center | Kansas City, Kansas, 66160, United States Lawrence Scott [email protected]
University of Kentucky | Lexington, Kentucky, 40536, United States Christina Payne [email protected]
Tulane University | New Orleans, Louisiana, 70112, United States Carol Rockwell [email protected]
John Hopkins Hospital | Baltimore, Maryland, 21205, United States Britany Zeglin [email protected]
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States Lauren Guthrie [email protected]
Boston Children's Hospital, Brigham & Women's Hospital | Boston, Massachusetts, 02115, United States Robert Fowler [email protected]
University of Michigan Health System | Ann Arbor, Michigan, 48109, United States Dawn Kruse [email protected]
Helen DeVos Children's Hospital | Grand Rapids, Michigan, 49546, United States Heather Mulroy [email protected]
The Minnesota Cystic Fibrosis Center | Minneapolis, Minnesota, 55455, United States CF Trials Contact [email protected]
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Tina Hicks [email protected]
University of Nebraska Medical Center | Omaha, Nebraska, 69198, United States James Melson [email protected]
The Cystic Fibrosis Center of Western New York | Buffalo, New York, 14203, United States Christine Roach [email protected]
Columbia University Cystic Fibrosis Program | New York, New York, 10032, United States Emily DiMango [email protected]
SUNY Upstate Medical University | Syracuse, New York, 13210, United States Mary Forell [email protected]
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, 27517, United States Margret Powell [email protected]
University of Cincinnati Medical Center | Cincinnati, Ohio, 45267, United States Nicole Hummel [email protected]
Cleveland Clinic Cystic Fibrosis Program | Cleveland, Ohio, 44195, United States Dave Weaver [email protected]
Nationwide Children's Hospital | Columbus, Ohio, 43205, United States Diana Gilmore [email protected]
Oregon Health Sciences University | Portland, Oregon, 97239, United States Brendan Klein [email protected]
University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Melissa Molter [email protected]
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, 15224, United States Elizabeth Hartigan [email protected]
Medical University of South Carolina | Charleston, South Carolina, 29425, United States Ashley Warden [email protected]
Vanderbilt Children's Hospital | Nashville, Tennessee, 37232, United States Brijesh Patel [email protected]
University of Texas Southwestern | Dallas, Texas, 75390, United States Ashley Keller [email protected]
Baylor College of Medicine | Houston, Texas, 77030, United States Tracy Mosely [email protected]
Intermountain Cystic Fibrosis Center | Salt Lake City, Utah, 84132, United States Kristyn Packer [email protected]
University of Washington Medical Center | Seattle, Washington, 98195, United States Teresa Gambol [email protected]
University of Wisconsin | Madison, Wisconsin, 53792, United States Sophia Chiron Stevens [email protected]
Froedtert & Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States Erin Hubertz [email protected]
Pays d'implantation

United States

Date de vérification

2021-03-01

Partie responsable

Type: Sponsor-Investigator

Affiliation des enquêteurs: Seattle Children's Hospital

Nom complet de l'enquêteur: Amalia Magaret

Titre d'enquêteur: Director of Statistical Research

Mots clés
A un accès étendu No
Parcourir l'état
Acronyme MAYFLOWERS
Informations sur la conception de l'étude

Modèle d'observation: Cohort

Perspective temporelle: Prospective

La source: ClinicalTrials.gov

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